Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04812028
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2021-03-19
Brief Title:
Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To use magnesium sulfate as adjuvant analgesia by implementing a treatment protocol in order to determine whether can benefit pediatric pain in post-operative transplanted patients and decrease overall opioid consumption
Detailed Description:
The post-operative ICU course for children receiving liver transplants and TPIAT total pancreatectomy with islet cell autotransplantation includes a number of different challenges one of which includes pain Pain is treated with both medications and approaches without medications such as music and other distraction techniques Opioids are one such effective pain medication which is universally used however like all medications has risks of certain side effects such as nausea constipation itching and others Modern research has searched for other medications and methods to treat pain in both children and adults In this study the investigators aim to apply one of these methods that has been shown to be effective in certain operative populations through a medicine called Magnesium-Sulfate which may be a safe way to decrease the use of other pain medications specifically opioids Magnesium is already a physiologic electrolyte the body uses which are consumed from certain foods Used as an IV medication to reach higher levels of magnesium can work to decrease pain via its action on specific nerve receptors Magnesium-Sulfate will be given at the beginning of transplant surgery for consented liver and TPIAT transplant patients and continue an infusion for 48 hours into their ICU course The investigators will monitor side effects and treat pain the same way otherwise the care team would without magnesium to determine whether there is any beneficial effect that can be applied to children in the future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None